🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04877522
Recruiting Phase 4

Asciminib Roll-over Study

NCT04877522 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2022-08-30
Last updated
2026-07-06

Condition(s) studied

Chronic Myelogenous LeukemiaLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Investigational drug(s) / intervention(s)

Asciminib single agentImatinibNilotinibBosutinibDasatinibAsciminib single agent pediatric formulation

Asciminib single agent: Taken orally, twice daily (BID) or once daily (QD), in fasting state

Imatinib: Taken orally, once daily, in the morning with low-fat meal

Nilotinib: Taken orally, twice daily, on an empty stomach

Bosutinib: Taken orally, once daily, with food

Dasatinib: Taken orally, once daily in a fasted state, 1 or 2 hours before a meal

Asciminib single agent pediatric formulation: Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.

Study summary

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Eligibility

Sex
ALL
Min age
7 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment. 2. Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures. Key Exclusion Criteria: 1. Participant has been discontinued from parent study treatment. 2. Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study. 3. Participant's ongoing treatment is currently approved and reimbursed at country level. 4. Pregnant or nursing (lactating) women. 5. Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment. 6. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information. 7. Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment: * Asymptomatic (grade 2) pancreatitis if not resolved within 28 days * QTcF\>480msec or inability to determine QTc interval * any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
Michigan Med University of Michigan Ann Arbor Michigan Recruiting
Memorial Sloan Kettering New York New York Recruiting
Oregon Health Sciences University Portland Oregon Active Not Recruiting
Texas Oncology Dallas Texas Recruiting
Uni Of TX MD Anderson Cancer Cntr Houston Texas Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Novartis Investigative Site CABA Buenos Aires Recruiting
Novartis Investigative Site Capital Federal Argentina Recruiting
Novartis Investigative Site Graz Austria Recruiting
Novartis Investigative Site Vienna Austria Recruiting
Novartis Investigative Site Rio de Janeiro Rio de Janeiro Completed
Novartis Investigative Site São Paulo São Paulo Completed
Novartis Investigative Site São Paulo São Paulo Completed
Novartis Investigative Site Varna Bulgaria Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Chongqing Chongqing Municipality Recruiting
Novartis Investigative Site Guangzhou Guangdong Recruiting
Novartis Investigative Site Zhengzhou Henan Recruiting
Novartis Investigative Site Wuhan Hubei Recruiting
Novartis Investigative Site Changchun Jilin Recruiting
Novartis Investigative Site Xian Shanxi Recruiting
Novartis Investigative Site Chengdu Sichuan Completed
Novartis Investigative Site Beijing China Active Not Recruiting
Novartis Investigative Site Beijing China Recruiting
Novartis Investigative Site Shanghai China Active Not Recruiting
Novartis Investigative Site Shenyang China Recruiting
Novartis Investigative Site Tianjin China Recruiting
Novartis Investigative Site Ostrava Poruba Recruiting
Novartis Investigative Site Brno Czechia Recruiting
Novartis Investigative Site Copenhagen Denmark Completed
Novartis Investigative Site Bordeaux France Recruiting
Novartis Investigative Site Lyon France Recruiting
Novartis Investigative Site Marseille France Recruiting
Novartis Investigative Site Nantes France Recruiting
Novartis Investigative Site Paris France Recruiting
Novartis Investigative Site Vandœuvre-lès-Nancy France Recruiting
Novartis Investigative Site Frankfurt am Main Hesse Recruiting
Novartis Investigative Site Jena Thuringia Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Kiel Germany Recruiting

+ 45 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04877522 on ClinicalTrials.gov ↗ ← All trials in the USA